510(k) K212161 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Mar 6, 2023 |
| Received | Jul 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212161
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.